On October 25, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported financial results and provided a business update for the third quarter ended September 30, 2018 (Press release, argenx, OCT 25, 2018, View Source [SID1234530147]).

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"The proof-of-concept data that we have generated in the last year from our Phase 2 clinical trials in generalized myasthenia gravis (gMG), immune thrombocytopenia (ITP) and pemphigus vulgaris (PV) support efgartigimod’s (ARGX-113) potential in severe autoimmune disease, and we are committed to advancing and expanding this clinical program as quickly as possible. We continue to see potential differentiation of our molecule among the anti-FcRn class of therapies in terms of tolerability, improvement in disease scores, and stage of development. We are now evaluating our lead candidate in four indications, two formulations to accommodate tailored therapy, and in one registration trial with another expected to launch next year," commented Tim Van Hauwermeiren, CEO of argenx. "Our second program, cusatuzumab (ARGX-110), will follow quickly as we enroll newly diagnosed, elderly acute myeloid leukemia (AML) patients in a Phase 2 clinical trial. We plan to show the full Phase 1 data in December during our annual American Society of Hematology (ASH) (Free ASH Whitepaper) workshop, along with the full dataset from the Phase 2 clinical trial of efgartigimod in ITP."

"We believe we have differentiated antibody design capabilities and continue to show this through reproducible value creation with the robust clinical datasets from our wholly-owned programs, successes from our collaborations including the in-licensing by AbbVie of ARGX-115, and the pipeline we grow using novel targets from esteemed academic institutions."

THIRD QUARTER 2018 AND RECENT HIGHLIGHTS:

Pipeline Updates:

Efgartigimod (ARGX-113):

Reported positive topline results from Phase 2 proof-of-concept trial of intravenous (IV) efgartigimod in primary ITP:

Well-tolerated, consistent with efgartigimod clinical trials to-date.

Clinically meaningful platelet count improvements seen across doses and ITP patient classifications, correlating with consistent reduction in Immunoglobulin G levels.

Showed separation from placebo at increasing response thresholds, with response rates of 46% and 58% in primary trial and first dosing of open-label extension study, respectively.

Announced plans to advance IV efgartigimod into Phase 3 development in ITP in second half of 2019 and subcutaneous efgartigimod into Phase 2 trial in ITP in first half of 2019.

Dosed first patient in global Phase 3 registration trial of efgartigimod in patients with gMG.

Phase 3 trial, if results are positive, expected to serve as basis to submit Biologics License Application (BLA) in U.S. and for marketing authorization in Japan, based on feedback from U.S. Food and Drug Administration (FDA) and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Data from Phase 2 proof-of-concept trial of efgartigimod in PV on track to read out in first half of 2019.

Announced chronic inflammatory demyelinating polyneuropathy (CIDP) as fourth indication for efgartigimod with Phase 2 proof-of-concept trial expected to start in first half of 2019.

Cusatuzumab (ARGX-110):

Enrollment ongoing of initial 21 patients in Phase 2 part of Phase 1/2 proof-of-concept trial of 10 mg/kg cusatuzumab in combination with standard of care azacytidine in newly diagnosed, elderly AML and myelodysplastic syndromes patients who are unfit for chemotherapy.

Corporate Updates:

AbbVie exercised its exclusive option to license ARGX-115, a novel immuno-oncology antibody targeting glycoprotein A repetitions predominant (GARP).

argenx received preclinical milestone in its strategic collaboration with Shire plc. The milestone, for which an undisclosed payment has been received, was triggered by Shire exercising its exclusive option to in-license an antibody discovered and developed using argenx’s proprietary SIMPLE Antibody platform and Fc engineering technologies.

FINANCIAL HIGHLIGHTS (as of September 30, 2018) (compared to financial highlights as of September 30, 2017)

Raised approximately $300.6 million in gross proceeds in U.S. public offering from sale of 3,475,000 American Depositary Shares (ADSs) at a price to the public of $86.50 per ADS; proceeds to be used to advance efgartigimod program in ITP, launch efgartigimod program in CIDP, further scale up manufacturing in advance of potential commercial operations, and expand argenx organization.

Operating income of €24.5 million (September 30, 2017: €30.5 million).

Total comprehensive loss of €36.5 million (September 30, 2017: €16.5 million).

Cash position of €582.3 million (cash, cash-equivalents and current financial assets) allowing argenx to pursue development of its pipeline in severe autoimmune diseases and cancer (September 30, 2017: €161.7 million).

UPCOMING CLINICAL MILESTONES

Present full dataset from Phase 2 proof-of-concept trial of efgartigimod in ITP at workshop around ASH (Free ASH Whitepaper) Annual Meeting (San Diego, December 3, 2018).

Report full data from Phase 1 dose-escalation trial of cusatuzumab in AML at workshop around ASH (Free ASH Whitepaper).

Report full data from Phase 2 proof-of-concept trial of efgartigimod in PV in first half of 2019.

Launch Phase 2 clinical trial in ITP using subcutaneous formulation of efgartigimod in first half of 2019.

Launch Phase 2 clinical trial of efgartigimod in CIDP in first half of 2019.

Q3 2018 FINANCIAL RESULTS:

Nine months ended

Nine months ended

Nine months ended

September 30,

Adjustments

September 30,

September 30,

2018

Adoption

2018

2017

(in thousands of €)

IAS 18

IFRS 15 (*)

IFRS 15

IAS 18

Variance

Revenue

17,892

2,031

19,924

28,422

(8,498)

Other operating income

4,594

4,594

2,090

2,504

Total operating income

22,487

2,031

24,518

30,512

(5,994)

Research and development expenses

(53,352)

(198)

(53,550)

(36,655)

(16,895)

Selling, general and administrative expenses

(18,245)

(18,245)

(7,339)

(10,906)

Operating loss

(49,111)

1,833

(47,278)

(13,482)

(33,796)

Financial income

1,983

1,983

88

1,895

Exchange gains/(losses)

8,826

8,826

(2,476)

11,302

Loss before taxes

(38,301)

1,833

(36,468)

(15,870)

(20,598)

Income tax benefit/(expense)

32

32

(597)

629

Loss for the period and total comprehensive loss

(38,269)

1,833

(36,436)

(16,467)

(19,969)

Net increase in cash, cash-equivalents and current financial assets compared to year-end 2017 and 2016

222,506

222,506

64,989

Cash, cash-equivalents and current financial assets at the end of the period

582,281

582,281

161,717

(*) The company has adopted IFRS 15 on January 1, 2018 using a modified retrospective approach. The impact of adopting IFRS 15 amounts to €1.8 million for the nine months ended September 30, 2018.

Total operating income was €24.5 million for the nine months ended September 30, 2018, compared to €30.5 million for the nine months ended September 30, 2017. The decrease in operating income in 2018 was due to a decrease of €8.5 million in revenue primarily related to the completion of the preclinical activities under the ongoing collaborations with LEO Pharma and AbbVie. The decrease in revenue was partially offset by an increase of €2.5 million in other operating income, mainly driven by an increase in payroll tax rebates for employing certain research and development personnel and higher grant income following the approval of two VLAIO grants in 2018.

Research and development expenses were €53.6 million for the nine months ended September 30, 2018, compared to €36.7 million for the nine months ended September 30, 2017. The increase in research and development expenses in 2018 was principally due to (i) an increase of €11.2 million in costs related to the advancement of the clinical development and manufacturing activities of argenx’s product candidates efgartigimod (notably with the start of a Phase 3 registration trial in efgartigimod), cusatuzumab and ARGX-117 and (ii) an increase of €6.2 million in share-based compensation expenses linked to the grant of stock options to the Company’s research and development employees (including an increase of €1.0 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 89 employees and consultants in its research and development functions on September 30, 2018, compared to 71 employees and consultants on September 30, 2017.

Selling, general and administrative expenses were €18.2 million for the nine months ended September 30, 2018, compared to €7.3 million for the nine months ended September 30, 2017. The increase in selling, general and administrative expenses in 2018 is mainly explained by an increase of €9.6 million of personnel expenses resulting primarily from an increase of €7.5 million in share-based compensation expenses linked to the grant of stock options to argenx’s selling, general and administrative employees (including an increase of €1.3 million in social security costs on stock options granted to certain Belgian and non-Belgian resident employees). argenx employed 31 employees and consultants in its selling, general and administration functions on September 30, 2018, compared to 19 employees and consultants on September 30, 2017.

Financial income and exchange gains amounted to €10.8 million for the nine months ended September 30, 2018, compared to financial income and exchange losses of €2.4 million for the nine months ended September 30, 2017, which was primarily attributable to €8.8 million of unrealized exchange rate gains on the Company’s cash, cash equivalents and current financial assets position in USD linked to the favorable fluctuation of the USD exchange rate in the nine months ended September 30, 2018.

argenx generated a loss for the period and total comprehensive loss of €36.5 million for the nine months ended September 30, 2018, compared to a loss for the period and total comprehensive loss of €16.5 million for the nine months ended September 30, 2017.

On September 30, 2018, argenx’s cash, cash equivalents and current financial assets amounted to €582.3 million, compared to €359.8 million on December 31, 2017. The significant increase in its cash balance on September 30, 2018 resulted from the follow-on U.S. public offering of ADSs on the Nasdaq Global Select Market completed in September 2018.

EXPECTED 2019 FINANCIAL CALENDAR:

February 28, 2019: FY 2018 business update and financial results

May 9, 2019: Q1 2019 business update and financial results

August 1, 2019: HY 2019 business update and financial results

October 24, 2019: Q3 2019 business update and financial results

On October 25, 2018 Geron Corporation (Nasdaq: GERN) reported that it will release its third quarter 2018 financial results after the market closes on Thursday, November 1, 2018 (Press release, Geron, OCT 25, 2018, View Source [SID1234530148]). The financial press release will be available on the Company’s website at www.geron.com/investors. Geron will host a conference call to discuss the third quarter results and recent events at 4:30 p.m. ET the same day.

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Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 7133129. Participants are advised to dial in at least 10 minutes prior to minimize any delay in joining the call. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

On October 25, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2018 and reaffirmed net sales and adjusted-diluted EPS guidance for full-year 2018 (Press release, West Pharmaceutical Services, OCT 25, 2018, View Source [SID1234530149]).

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Executive Summary

Third-quarter 2018 reported net sales of $431.7 million grew 8.4% over the prior-year quarter. At constant currency, organic sales growth was 9.6%.
Third-quarter 2018 reported-diluted EPS was $0.73, as compared to $0.67 in the same period last year. Excluding restructuring-related and other charges, third-quarter 2018 adjusted-diluted EPS was $0.76, a 13% increase over the same period last year.
The Company reaffirms full-year 2018 net sales and adjusted-diluted EPS guidance. The Company expects full-year 2018 capital spending to be in a new range of between $110 million and $120 million, compared to a prior range of between $120 million and $130 million.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"We had solid third-quarter 2018 organic sales growth driven by a high-single digit Proprietary Products segment increase and a strong double-digit increase in the Contract-Manufactured Products segment," said Eric M. Green, President and Chief Executive Officer. "Our high-value product (HVP) portfolio continues to do well, led by strong double-digit sales growth in our Westar RS and RU, NovaPure and Crystal Zenith products.

"I am pleased with the performance of our Global Operations team, which is successfully executing on all of their planned initiatives. The Company continues to raise the bar on industry-leading quality and service targets, and the team is expanding capacity to support long-term demand forecasts by increasing plant utilization within our worldwide network. As a result, we are revising our capital spending guidance to be in a new range of between $110 million and $120 million, down from prior projections of $120 million to $130 million."

Mr. Green concluded, "We remain on track to achieve our full-year 2018 financial targets. Our markets are stable, and West continues to address the needs of our customers by providing the quality, availability and scientific excellence required to support their regulated injectable and diagnostic products."

Third-Quarter 2018 Financial Results (comparisons to prior-year period)

Third-quarter 2018 reported net sales of $431.7 million grew 8.4% over the prior-year quarter sales of $398.2 million. At constant currency, organic sales growth was 9.6%.

Proprietary Products segment organic sales growth was 6.6%. By market unit, third-quarter 2018 Proprietary Products segment sales growth was led by double-digit growth in the Pharma Market Unit. Generics Market Unit organic sales growth was mid-single digits, and Biologics Market Unit organic sales declined mid-single digits. Biologics sales were impacted by a decline in self-injection delivery device sales associated with lower than expected commercial sales of the underlying drug product. Contract-Manufactured Products segment organic sales growth was 20.1%. This growth was driven by continued escalation of demand for diabetes-related diagnostic and drug delivery devices.

Third-quarter 2018 gross profit margin was 31.4%, in line with the same period last year. Proprietary Products segment gross margin increased by 120 basis points, due to higher efficiencies, favorable volume/mix and increased sales prices, partially offset by increased labor costs, unabsorbed overhead from the start-up of our Waterford facility and higher raw material costs. Contract-Manufactured Products segment gross margin declined by 200 basis points mainly due to unabsorbed overhead from plant consolidation activities and start-up costs associated with the expediting of the launch of new programs. We expect margins in that segment to revert to more normal levels going forward.

As of January 1, 2018, the Company adopted new rules for pension accounting. Instead of recognizing pension gains or losses in the "Selling, general and administrative expenses" line on the income statement, these gains or losses are now located "below the line" in nonoperating income. The Company has restated all prior periods to allow year-over-year comparisons with 2018 performance.

Third-quarter 2018 reported operating profit margin was 14.1%, as compared to 15.8% in the same period last year. Excluding restructuring costs and other charges, third-quarter 2018 adjusted operating profit margin was 14.6%. In the third-quarter 2017, the Company had a benefit from reimbursed costs associated with a technology that was subsequently licensed to a third party, which increased other operating income in the period by $9.1 million. Excluding this prior year benefit, third-quarter 2018 adjusted operating profit margin would have expanded by 110 basis points.

For the third-quarter 2018, reported income tax expense was $8.0 million, representing a reported effective tax rate of 13.1%. Tax benefits from stock-based compensation were $7.7 million in the third-quarter 2018, as compared to $4.8 million in the same period last year. This amount was higher-than-expected for the quarter, as prior Company guidance anticipated $9 million for the second-half of 2018. The Company expects the remainder to come in the fourth-quarter 2018. Excluding the impact of tax benefits from stock-based compensation, the reported effective tax rate would have been 25.7%.

Full-Year 2018 Financial Guidance and Long-Term Outlook

The Company is reaffirming its full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. The Company assumes an expected translation exchange rate of $1.15 per euro for the remainder of the year.

The Company is also reaffirming its full-year 2018 adjusted-diluted EPS guidance to be in a range of between $2.80 to $2.90. The lower end of the guidance range reflects the Company’s expected performance and approximately $1 million of tax benefits from stock-based compensation in the fourth-quarter of 2018.

The Company is revising its full-year 2018 capital spending guidance. The new range is expected to be in a range of between $110 million and $120 million, which is below the prior range of between $120 million and $130 million.

For 2019 and beyond, the Company reiterates its long-term financial construct and expectations for above-market sales growth with expanding gross and operating profit margins. As has been its practice, the Company will provide full-year 2019 guidance on its Q4 2018 conference call.

Third-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 8341499.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, November 1, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 8341499.

On October 25, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address liver and inflammatory diseases, reported that its CEO, Dr. Pnina Fishman, will present at The NYC Oncology Investor Conference 2018 View Source to take place on October 30-31 (Press release, Can-Fite BioPharma, OCT 25, 2018, View Source [SID1234530150]). Her lecture will be delivered on the 31st at 11:40 am.

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Dr. Fishman will present the molecular mechanism mediating the anti-cancer effects of Namodenoson and will describe clinical data from the Company’s earlier Phase I/II liver cancer study. In addition, she will present the status of the current Phase II study in patients with advanced hepatocellular carcinoma, Child Pugh B.

The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Advanced liver cancer is categorized into 3 subclasses including Child Pugh A, mostly treated with Nexavar, Child Pugh B and Child Pugh C. Although a few drugs for the treatment of advanced liver cancer have recently launched, none are specifically aimed at treating patients who have reached the Child Pugh B stage. This represents a major unmet need and potentially positions Namodenoson as an important drug candidate to treat this patient population.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

"We are pleased to present at the NYC Oncology Conference and share with investors our unique approach to treat patients with advanced HCC. This tumor is resistant to chemotherapy whereas Namodenoson has shown in an earlier pre-clinical study to induce specific apoptosis towards the liver cancer cells while sparing the normal liver cells," commented Dr. Pnina Fishman, company CEO.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On October 25, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH) (TSX:AUP) reported that it will release its third quarter 2018 financial results on Thursday, November 8, 2018, after the market closes (Press release, Aurinia Pharmaceuticals, OCT 25, 2018, View Source [SID1234530151]). Aurinia’s management will host a conference call to discuss the company’s third quarter 2018 financial results and provide a general business update.

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The conference call and webcast is scheduled for November 8, 2018 at 4:30pm EDT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.